Strategy-based Cognitive Rehabilitation for Childhood Brain Tumour: Protocol for an Acceptability and Feasibility Trial of the Fatigue, Learning, and Memory Enrichment (FLaME) intervention

ABSTRACT Background Medical treatments have improved survival rates for paediatric brain tumour (PBT), but the condition and treatment continue to be associated with significant cognitive morbidity. Nearly all survivors will experience some degree of cognitive impairment (neurocognitive ‘late effects’) that has a cascading impact on the development of intellectual and academic skills, quality of life, mental health, vocational attainment, and functional independence. Longstanding cognitive fatigue is also a prevalent symptom for survivors of PBT and further impacts engagement with therapeutic interventions and quality of life. Cognitive rehabilitation is recommended in national healthcare guidance and frequently requested by patients and families but rarely implemented due to a limited evidence base and poor feasibility and acceptability. There are currently no therapeutic interventions for cognitive fatigue for PBT survivors. Aims & Objectives We aim to establish feasibility, acceptability, and preliminary efficacy for strategy-based cognitive rehabilitation for PBT. The study will determine if there is benefit to feasibility and acceptability when cognitive fatigue management is integrated to cognitive rehabilitation. Methods Thirty-six 7-17 years olds diagnosed with PBT will be recruited from Great Ormond Street Hospital. Participants will be randomised to either 1) a 12-week cognitive rehabilitation intervention with integrated cognitive fatigue management, 2) a 6-week cognitive rehabilitation intervention alone, or 3) standard care. All participants will have received neuropsychological assessment identifying difficulties with cognition and fatigue. Feasibility (e.g., attrition, retention, adherence) will be assessed through the trial. Acceptability will be measured throughout using questionnaires and interviews based on the Theoretical Framework for Acceptability and satisfaction rating scale. Preliminary effectiveness data will be gathered pre- and post-intervention using standardised measures of cognitive skills, fatigue, quality of life, % school attendance, and goal-based outcomes. Outcome The findings will be used to determine the appropriate rehabilitation intervention for a larger, multicentre randomised controlled trial. PLAIN ENGLISH SUMMARY Medical treatments have improved survival rates for children with brain tumours. However, most children experience long-term difficulties with ‘cognition’ (thinking skills such as memory and paying attention) and cognitive fatigue (excessive mental tiredness) after treatment. Thinking difficulties and fatigue can affect a child’s ability to learn, and their social and emotional wellbeing. National guidance recommends treatment called ’cognitive rehabilitation’ which teaches skills to improve or manage cognitive difficulties. Families often request this, but it is not usually available due to little research. Fatigue may also get in the way of children using and benefiting from cognitive rehabilitation. No research study yet has offered a fatigue treatment for children recovering from brain tumours. The study aims to see if it is practical and helpful to families to provide cognitive rehabilitation for children affected by brain tumours. The treatment focuses on strategies to help cognition. We will see if adding strategies to manage fatigue helps. We will include thirty-six 7–17-year-olds who have been cared for at Great Ormond Street Hospital for brain tumour. All participants will have had an assessment describing cognitive strengths and weaknesses as part of usual care. Participants will be randomly allocated to one of three groups: 1) cognitive rehabilitation with fatigue management (12 weeks), 2) cognitive rehabilitation only (6 weeks), or 3) usual care. Each child and their carer will complete questionnaires before, during, and after the treatment, and an interview at the end of the treatment. This information will help the researchers see if families find the treatment helpful and practical to take part in, and if adding fatigue strategies is beneficial. Researchers will look at information such as the number of appointments attended, feedback about the treatment, and information about fatigue levels, cognition, and wellbeing. The findings will be used to develop a UK-wide study.